Center for iPS Cell Research and Application, Kyoto University

Utilized for the procurement of reagents and similar materials used in the production of iPS cells and related applications

We, Kyoto University’s iPS Cell Research Foundation – based on our philosophy of providing the best iPS cell technology at an affordable price – promote the business of bridging technologies such as the manufacture of iPS cells and quality assessment to industry.

Our projects include the “iPS Cell Stock Project” and the “my iPS Project”. In the iPS Cell Stock Project we are collecting blood from healthy donors who are expected to lower the risk of immune rejection, reprogramming its cells into iPS cells and keeping them under strict quality control. In the my iPS Project we are developing technology that will manufacture iPS cells derived from patients’ own cells.

At present, several samples of iPS cells are produced every year and each sample costs around 40 million yen (approx. $365,000). By 2025, the my iPS Project aims to produce 1,000 samples of iPS cells per year at a cost of around 1 million yen per sample.

We use Questetra in the operations of purchasing reagents and medical materials needed for the manufacture of iPS cells.

Report Leakages Reduced by 80%

In the manufacture of iPS cells we must comply with Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Drugs and Quasi-drugs, in which the manufacturing of pharmaceutical products must be verified so that it conforms to the established quality standards, and the manufacturing process must be recorded and appropriately controlled.

In manufacturing control and quality control we create many GMP-defined manufacturing record documents. For my iPS to manufacture 1000 samples per year the operations related to the creation and storage of GMP documents must also be handled efficiently. Before my iPS production increases in the future, we decided to start with the purchasing operations so that the staff can get used to managing the business via Questetra.

The purchasing operation consists of the following 4 steps:

1. Application/Approval: the staff responsible for purchasing in each department makes a purchase application, which is then approved by their manager.
2. Purchase order: upon approval, the purchasing staff will process the order.
3. Reporting deliveries: the staff responsible for the purchase should report the delivery note number to the accounting department as soon as the delivery is made.
4. Payment: the accounting department checks the invoices and delivery note numbers received and make a payment.

In the past, we processed applications and approvals by email. As a result, the delivery report in step 3 was frequently not carried out properly. The staff in the accounting department looked at the invoices received and had to confirm who had placed the orders and whether it had been delivered. This was placing a heavy burden on the staff.

zAs a result of using Questetra to digitize these processes the purchasing staff can see at a glance the unprocessed delivery reports, and the number of unprocessed reports has been reduced by about 80%. Even if a delivery report has not been processed, the staff in the accounting department can immediately see the outstanding purchase orders, which makes it easier to remind the purchasing staff to process the report.

Pave the Way for GMP Document Management in 2021

The ability to work with Box is a standard feature of Questetra.

We use Box on a daily basis for file sharing within the foundation and the private companies we work together with for joint research. As Box is always used for work involving documents, it was essential for us that the system for managing GMP documents could be easily linked to Box.

In the purchasing operation when a delivery report is processed, a CSV file generated from the information entered in the report at that time is automatically uploaded to Box, which is then used by the accounting department for accounting purposes.

Planning to expand the number of applicants and implement automated order emails

We hope to determine whether to apply Questetra to GMP document management by the end of 2021.

We will also be working on two areas of our purchasing operation:

1. Allowing applications to be accepted from people who work in the same institution, e.g. co-researchers.
2. Automating the order process for frequently ordered items.

Regarding the former, we will almost be able to achieve this by using the function that allows users who do not have a Questetra login ID to apply. And for the latter, we will be able to automatically send an email with the order details to our usual supplier.

(April 2021)